PainNCT04862871
Enhancing Analgesia in Chronic Pain Through Exercise
A study testing Physical Activity - Pediatric Pain Rehabilitation Center in people with Pain and Chronic Widespread Pain, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Background: Current pain management strategies for pediatric patients are not integrating the analgesic potential of movement-based therapies. To date, experiencing a painful stimulus has been known to disrupt motor activity in an attempt to minimize injury. Read more about this study
- Who is it for?
- Ages 10 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Chronic Widespread Pain, Fibromyalgia
- What is being tested?
- Physical Activity - Pediatric Pain Rehabilitation Center
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Otherwise healthy participants between the ages of 10 and 24
- Actively on the waitlist for, or having completed the exercise program at the PPRC
- Comprehension of instructions
- Parental consent for minors
- Weight less than 250 lbs - limit of MRI table
- Clinical diagnosis of Chronic Widespread Pain
Who cannot join
- Preventative medications and opioids
- Metallic implants that will pose harm to the subject (e.g., pacemaker) and/or affect the dat (e.g., braces)
- Significant medical disease (systemic or CNS).
- Active suicidality, psychosis, diagnosed eating disorders, and/or other severe clinically diagnosed neuro-psychiatric conditions
- Pregnant
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Scott A Holmes, PhD, 617-919-6648, scott.holmes@childrens.harvard.edu
About this study
Official title: Enhancing Analgesia in Chronic Pain Through Exercise: Responsivity of Sensory-Motor Networks and Factors That Moderate the Analgesic Response
Background: Current pain management strategies for pediatric patients are not integrating the analgesic potential of movement-based therapies. To date, experiencing a painful stimulus has been known to disrupt motor activity in an attempt to minimize injury. However, physical activity, even when it increases ongoing pain initially, has been shown to significantly reduce pain symptoms eventually through neuromodulation. In both acute and chronic pain cohorts, exercise protocols and neuromodulation paradigms have produced exercise-related analgesia. Problem: It is not currently understood which brain regions are implicated in exercise-based analgesia and what brain regions moderate this response.
Approach: The investigators intend to provide a physical activity intervention designed to promote exercise-induced analgesia. This intervention will be performed in a group of pediatric subjects with Chronic Widespread Pain Disorder. An exercise (n=10), no exercise (n=10) and healthy control (n=10) group will be recruited. Aims: This study has three aims: (1) To understand how thermal pain sensitivity, pain symptoms and motor performance are impacted in patients with chronic pain after an exercise-based intervention. (2) To evaluate the brain regions involved in a simple motor task as well as how motor activity influences activity in pain regions of the brain. (3) To evaluate the network structure of the brain, with special emphasis on motor and pain regions, in youth with a pain disorder who have undergone an exercise-based intervention. Exercise-based therapy in pediatric subjects with a chronic pain condition is predicted to reduce pain symptom reporting through biasing activity in pain regions during motor performance. Significance: Findings from this investigation will address the clinical side of pain management strategies and provide potential therapeutic targets and feasibility data. The investigators anticipate that findings will show how pain and motor regions of the brain interact at the network level and if this interaction can be modulated through exercise. Findings will also evaluate the brain regions that mediate the analgesic properties of an exercise-based pain therapy and provide future therapeutic targets.
Read the detailed description
This investigation is aimed at understanding how an exercise program currently performed at the Pediatric Pain Rehabilitation Center (PPRC) at Boston Children's Hospital, designed for individuals with chronic widespread pain is associated with pain relief and how this pain relief relates to changes in the brain. The specific aims/objectives are to explore the following:
Aim 1 - Pain and sensorimotor behavior: To understand how thermal pain sensitivity, pain symptoms and motor performance are impacted in children with chronic pain after an exercise-based intervention. Sensory testing (for Hot \& Cold) will be collected using Quantitative Sensory Testing (QST) to establish pain thresholds. To address motor performance, we will perform the Bruininks-Oseretsky Test (BOT) 1 of motor proficiency (examining muscle power, strength, endurance). Pain symptom levels will be evaluated using self-report questionnaires that address fear of pain, pain catastrophizing, and pain symptom load.
Aim 2 - Defining hierarchies during motor performance: To evaluate the brain regions involved in a simple motor task as well as how motor activity influences activity in pain regions. Participants will perform a tapping task within the MRI scanner to evaluate the brain regions that are active during motor control. 2 Functional magnetic resonance images will be processed using dynamic causal modeling (DCM) to evaluate effective connectivity (Figure 2) during task performance. Brain regions evaluated in DCM will be defined by the healthy control cohort.
Aim 3 - Network structure: To evaluate the network structure of the brain, with emphasis on motor and pain regions, in persons with a pain disorder who have undergone an exercise intervention. Graph theory analyses implemented using resting-state functional magnetic resonance imaging will be performed to extract metrics reflecting network efficiency, nodal degree, and nodal centrality. Structural metrics (e.g., cortical thickness and white matter connectivity) will be collected as nuisance variables. Correlation analyses will be performed between network metrics and behavior (fear of pain, pain catastrophizing, motor performance) to evaluate their influence over network reorganization observed from the exercise intervention. Brain regions that define canonical pain and motor networks will be indexed from the healthy control group.
- Conditions
- Pain, Chronic Widespread Pain, Fibromyalgia
- Being tested
- Physical Activity - Pediatric Pain Rehabilitation Center
- Medical subject headings
- Pain, Chronic Pain, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity - Pediatric Pain Rehabilitation CenterBehavioural
While admitted to the Pediatric Pain Rehabilitation Center program, patients receive 1-3 hours of individual and group physical therapy 5 times per week and completed a 30-60 minute home exercise program 9 times per week. The median length of stay for the program is 5 weeks. The amount of aerobic exercise prescribed is individualized to each patient and ranged from 10-20 minutes per session. The duration of aerobic exercise prescribed progressed by 5-10 min weekly until the child reached 20-30 minutes. Patients are instructed to reach a moderate to vigorous intensity of exercise (defined at 5-7/10 rate of perceived exertion). The mode of exercise varied dependent on patient ability and interest. Typical modes of exercise included: walking, running, stationary biking, swimming, sports (i.e., soccer, dance), and online aerobic workouts. Patients were prescribed an individualized 30-60 minute discharge home program using the same structure upon completing the program.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | No intervention | A cohort (n=10) of participants will be recruited who do not have any neurological conditions and are age and sex-matched to participants in Arms 2 and 3. |
| Chronic Widespread Pain | No intervention | A cohort (n=10) of participants who have not yet begun the exercise program and are currently on the waitlist for the exercise program at the PPRC |
| Chronic Widespread Pain - Exercise | Active comparator | A cohort (n=10) of participants who have completed the exercise program at the PPRC. These individuals will be evaluated the day of their last treatment visit Receives: Behavioral: Physical Activity - Pediatric Pain Rehabilitation Center |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in effective connectivity
Difference in effective connectivity between motor and pain regions of the brain between persons who have completed the PPRC intervention and those on the waitlist. Whole-brain effective connectivity will be evaluated and compared between groups that will be age and sex-matched. Effective connectivity will be calculated using dynamic causal modeling and evaluated using a tapping task. Effective connectivity will be calculated from a motor task requiring participants to complete an active (tapping) and rest (no tapping) condition.
Measured: 8 months
Secondary outcomes (1)
Thermal sensitivity
Quantitative sensory testing (QST) will be used to evaluate thermal sensitivity to hot and cold stimulus paradigms. The outcome measure of interest will be participants self-reported pain ratings using a visual analogue scale (VAS) from 0 (minimum - no pain) to 10 (maximum - high pain) at specific levels of thermal sensitivity.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 Apr 2022
- Primary completionAug 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be evaluated in three independent groups (healthy controls, participants who have completed an exercise program, participants who are waiting to complete an exercise program).
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Holmes, Boston Children's Hospital
- Investigators
- Scott Holmes, PhD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862871
- Sponsor's protocol ID
- IRB-P00034939
- Status last verified
- May 2022
- First submitted
- 16 Apr 2021
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are currently no plans to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Analgesia in Chronic Pain Through Exercise: Responsivity of Sensory-Motor Networks and Factors That Moderate the Analgesic Response
- ClinicalTrials.gov ID
- NCT04862871
- Acronym / sponsor ID
- IRB-P00034939
- Conditions
- Pain, Chronic Widespread Pain, Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Current pain management strategies for pediatric patients are not integrating the analgesic potential of movement-based therapies. To date, experiencing a painful stimulus has been known to disrupt motor activity in an attempt to minimize injury. However, physical activity, even when it increases ongoing pain initially, has been shown to significantly reduce pain symptoms eventually through neuromodulation. In both acute and chronic pain cohorts, exercise protocols and neuromodulation paradigms have produced exercise-related analgesia. Problem: It is not currently understood which brain regions are implicated in exercise-based analgesia and what brain regions moderate this response.
Approach: The investigators intend to provide a physical activity intervention designed to promote exercise-induced analgesia. This intervention will be performed in a group of pediatric subjects with Chronic Widespread Pain Disorder. An exercise (n=10), no exercise (n=10) and healthy control (n=10) group will be recruited. Aims: This study has three aims: (1) To understand how thermal pain sensitivity, pain symptoms and motor performance are impacted in patients with chronic pain after an exercise-based intervention. (2) To evaluate the brain regions involved in a simple motor task as well as how motor activity influences activity in pain regions of the brain. (3) To evaluate the network structure of the brain, with special emphasis on motor and pain regions, in youth with a pain disorder who have undergone an exercise-based intervention. Exercise-based therapy in pediatric subjects with a chronic pain condition is predicted to reduce pain symptom reporting through biasing activity in pain regions during motor performance. Significance: Findings from this investigation will address the clinical side of pain management strategies and provide potential therapeutic targets and feasibility data. The investigators anticipate that findings will show how pain and motor regions of the brain interact at the network level and if this interaction can be modulated through exercise. Findings will also evaluate the brain regions that mediate the analgesic properties of an exercise-based pain therapy and provide future therapeutic targets.
Detailed description
This investigation is aimed at understanding how an exercise program currently performed at the Pediatric Pain Rehabilitation Center (PPRC) at Boston Children's Hospital, designed for individuals with chronic widespread pain is associated with pain relief and how this pain relief relates to changes in the brain. The specific aims/objectives are to explore the following:
Aim 1 - Pain and sensorimotor behavior: To understand how thermal pain sensitivity, pain symptoms and motor performance are impacted in children with chronic pain after an exercise-based intervention. Sensory testing (for Hot \& Cold) will be collected using Quantitative Sensory Testing (QST) to establish pain thresholds. To address motor performance, we will perform the Bruininks-Oseretsky Test (BOT) 1 of motor proficiency (examining muscle power, strength, endurance). Pain symptom levels will be evaluated using self-report questionnaires that address fear of pain, pain catastrophizing, and pain symptom load.
Aim 2 - Defining hierarchies during motor performance: To evaluate the brain regions involved in a simple motor task as well as how motor activity influences activity in pain regions. Participants will perform a tapping task within the MRI scanner to evaluate the brain regions that are active during motor control. 2 Functional magnetic resonance images will be processed using dynamic causal modeling (DCM) to evaluate effective connectivity (Figure 2) during task performance. Brain regions evaluated in DCM will be defined by the healthy control cohort.
Aim 3 - Network structure: To evaluate the network structure of the brain, with emphasis on motor and pain regions, in persons with a pain disorder who have undergone an exercise intervention. Graph theory analyses implemented using resting-state functional magnetic resonance imaging will be performed to extract metrics reflecting network efficiency, nodal degree, and nodal centrality. Structural metrics (e.g., cortical thickness and white matter connectivity) will be collected as nuisance variables. Correlation analyses will be performed between network metrics and behavior (fear of pain, pain catastrophizing, motor performance) to evaluate their influence over network reorganization observed from the exercise intervention. Brain regions that define canonical pain and motor networks will be indexed from the healthy control group.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be evaluated in three independent groups (healthy controls, participants who have completed an exercise program, participants who are waiting to complete an exercise program).
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | No intervention | –A cohort (n=10) of participants will be recruited who do not have any neurological conditions and are age and sex-matched to participants in Arms 2 and 3. |
| Chronic Widespread Pain | No intervention | –A cohort (n=10) of participants who have not yet begun the exercise program and are currently on the waitlist for the exercise program at the PPRC |
| Chronic Widespread Pain - Exercise | Active comparator | Behavioral: Physical Activity - Pediatric Pain Rehabilitation CenterA cohort (n=10) of participants who have completed the exercise program at the PPRC. These individuals will be evaluated the day of their last treatment visit |
Who may qualify
- Ages
- 10 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Otherwise healthy participants between the ages of 10 and 24
- Actively on the waitlist for, or having completed the exercise program at the PPRC
- Comprehension of instructions
- Parental consent for minors
- Weight less than 250 lbs - limit of MRI table
Key exclusion criteria (6 listed)
- Preventative medications and opioids
- Metallic implants that will pose harm to the subject (e.g., pacemaker) and/or affect the dat (e.g., braces)
- Significant medical disease (systemic or CNS).
- Active suicidality, psychosis, diagnosed eating disorders, and/or other severe clinically diagnosed neuro-psychiatric conditions
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity - Pediatric Pain Rehabilitation CenterWhile admitted to the Pediatric Pain Rehabilitation Center program, patients receive 1-3 hours of individual and group physical therapy 5 times per week and completed a 30-60 minute home exercise program 9 times per week. The median length of stay for the program is 5 weeks. The amount of aerobic exercise prescribed is individualized to each patient and ranged from 10-20 minutes per session. The duration of aerobic exercise prescribed progressed by 5-10 min weekly until the child reached 20-30 minutes. Patients are instructed to reach a moderate to vigorous intensity of exercise (defined at 5-7/10 rate of perceived exertion). The mode of exercise varied dependent on patient ability and interest. Typical modes of exercise included: walking, running, stationary biking, swimming, sports (i.e., soccer, dance), and online aerobic workouts. Patients were prescribed an individualized 30-60 minute discharge home program using the same structure upon completing the program. | Behavioural | Chronic Widespread Pain - Exercise |
Primary outcome
Change in effective connectivity
Time frame: 8 months
Difference in effective connectivity between motor and pain regions of the brain between persons who have completed the PPRC intervention and those on the waitlist. Whole-brain effective connectivity will be evaluated and compared between groups that will be age and sex-matched. Effective connectivity will be calculated using dynamic causal modeling and evaluated using a tapping task. Effective connectivity will be calculated from a motor task requiring participants to complete an active (tapping) and rest (no tapping) condition.
1 secondary outcome
Thermal sensitivity
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: No. There are currently no plans to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Holmes, PhD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity - Pediatric Pain Rehabilitation Center in people with Pain and Chronic Widespread Pain, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Scott Holmes, PhD (6179196648, scott.holmes@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in effective connectivity (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.